Number of subjects with loss of therapeutic response to levoketoconazole upon withdrawing to placebo compared with the proportion of subjects with loss of therapeutic response upon continuing treatment with levoketoconazole.

35

All

18 Years and older (Adult, Senior)

NCT03277690

COR-2017-01

September 26, 2017

May 30, 2018

July 1, 2018

September 11, 2017

February 12, 2018

UCLA School of Medicine, Medicine/Endocrinology Dept.Los Angeles, California, United States

The difference (in percent) in false positive DXM-tests comparing the outcome of all tests with all tests excluding those with s-DXM below the the cut-off specified below.

Calculate the positive likelihood ratio [(1-sensitivity)/specificity] for the short DXM-test in the assessment of Cushing's syndrome (CS), after excluding those with s-DXM below the DXM cut-off specified in the primary endpoint.

Calculate the negative likelihood ratio [(1-sensitivity)/specificity] for the short DXM-test in the assessment of Cushing's syndrome, after excluding those with s-DXM below the DXM cut-off specified in the primary endpoint.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institutes of Health Clinical Center (CC)

NIH

Observational Model: Cohort

Time Perspective: Prospective

Recruit a diverse population of adult subjects with a known or suspected endocrine or metabolic disorder in order to provide NICHD investigators and trainees with hands-on experience related to the diagnosis, management, treatment, and follow-up...

750

All

18 Years to 100 Years (Adult, Senior)

NCT02830308

16012516-CH-0125

July 9, 2016

December 31, 2036

December 31, 2036

July 12, 2016

February 6, 2018

National Institutes of Health Clinical CenterBethesda, Maryland, United States